The biosimilar road in inflammatory bowel disease: The right way?

Abstract The biologicals have led to dramatic changes in the management of immune-mediated diseases, and the subsequent development of their biosimilars may reduce the high costs of these agents. However, there remain concerns about the true equivalence of a biosimilar and its reference product, as...

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Bibliographic Details
Published in:Baillière's best practice & research. Clinical gastroenterology 2014-06, Vol.28 (3), p.465-471
Main Authors: Fiorino, Gionata, MD, PhD, Danese, Silvio, MD, PhD
Format: Article
Language:English
Subjects:
Biological products
Biosimilar pharmaceuticals
Biosimilar Pharmaceuticals - adverse effects
Biosimilar Pharmaceuticals - therapeutic use
Clinical trials
Cost control
Cost reduction
Drug dosages
Drug therapy
Gastroenterology and Hepatology
Humans
Inflammatory bowel disease
Inflammatory Bowel Diseases - drug therapy
Infliximab
Manufacturing
Pharmaceutical industry
Post marketing product surveillance
Rheumatology
Studies
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Summary:Abstract The biologicals have led to dramatic changes in the management of immune-mediated diseases, and the subsequent development of their biosimilars may reduce the high costs of these agents. However, there remain concerns about the true equivalence of a biosimilar and its reference product, as well as around immunogenicity of these agents in IBD, although studies on rheumatoid arthritis support the similarity of biosimilars and their originators. Many of the biologicals are approved for multiple indications, but it is not always possible to extrapolate across indications for the corresponding biosimilars. For both reference agents and biosimilars, rare adverse events and long-term efficacy and safety can only be assessed through post marketing surveillance; therefore, particular emphasis should be placed on the traceability of these agents in clinical practice. Lastly, based on current data, biosimilars cannot be considered simple substitutes of reference products in IBD, unless demonstrated by well-designed randomized controlled trials.
ISSN:1521-6918
1532-1916
DOI:10.1016/j.bpg.2014.04.006